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Trial record 9 of 14 for:    Atrial Fibrillation, Familial, 12

DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS)

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ClinicalTrials.gov Identifier: NCT00157820
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 21, 2012
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Ventricular Tachycardia
Ventricular Fibrillation
Defibrillators, Implantable
Interventions Device: Single Chamber Implantable Cardioverter Defibrillator
Device: Dual Chamber implantable cardioverter defibrilator
Enrollment 354
Recruitment Details Patients were eligible if they met a standard Class I indication for a Single Chamber-Implantable Cardioverter Defibrillator (ICD) according to the 1998 ACC/AHA guidelines. Every patient eligible for ICD was screened at each study centre. Follow-up started immediately after randomization.
Pre-assignment Details

The Dual chamber true (DC true) and Single chamber simulated (SC sim) arms crossed over after 8 months. All other crossovers were considered ‘premature crossovers’ and had to be authorized by an independent Adverse Events Advisory Committee.

A 1-month wash out period was implemented after programmed crossover.

Arm/Group Title SC True SC Simulated Then DC True DC True Then SC Sim
Hide Arm/Group Description Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes) Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes. Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated
Period Title: Randomized
Started 118 116 120
Completed 111 111 112
Not Completed 7 5 8
Reason Not Completed
Physician Decision             4             2             3
Withdrawal by Subject             1             2             3
Protocol Violation             2             1             2
Period Title: 1st 8 Month
Started 111 111 112
Completed 103 99 106
Not Completed 8 12 6
Reason Not Completed
Death             7             8             3
Lost to Follow-up             1             2             1
Premature cross-over             0             2             2
Period Title: 1 Month Wash Out Period
Started 103 101 [1] 108 [2]
Completed 103 101 108
Not Completed 0 0 0
[1]
2 patients had crossed over prematurely in SC sim period, that are now carried to DC true period
[2]
2 patients had crossed over prematurely in DC true period, that are now carried to SC sim period
Period Title: 2nd 8 Months
Started 103 101 108
Completed 98 88 94
Not Completed 5 13 14
Reason Not Completed
Death             3             1             3
Lost to Follow-up             1             5             2
Premature cross-over             1             7             9
Arm/Group Title SC True SC Simulated Then DC True DC True Then SC Sim Total
Hide Arm/Group Description Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes) Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes. Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm") then programmed as Single Chamber simulated Total of all reporting groups
Overall Number of Baseline Participants 111 111 112 334
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 112 participants 334 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
63
  56.8%
61
  55.0%
53
  47.3%
177
  53.0%
>=65 years
48
  43.2%
50
  45.0%
59
  52.7%
157
  47.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 111 participants 112 participants 334 participants
63  (10) 62  (11) 66  (9) 64  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 112 participants 334 participants
Female
11
   9.9%
21
  18.9%
20
  17.9%
52
  15.6%
Male
100
  90.1%
90
  81.1%
92
  82.1%
282
  84.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 112 participants 334 participants
Spain 43 44 44 131
Germany 29 29 31 89
Italy 21 21 19 61
Israel 9 8 9 26
United Kingdom 6 6 6 18
Portugal 3 3 3 9
LVEF   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 111 participants 111 participants 112 participants 334 participants
35  (13) 39  (14) 34  (12) 36  (13)
[1]
Measure Description: Left Ventricle Ejection Fraction (percentage)
1.Primary Outcome
Title CSAE-score Rate(Clinical Significant Adverse Events Score Rate)
Hide Description Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.
Time Frame 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title SC True SC Simulated DC True
Hide Arm/Group Description:
Allocated to Single Chamber ICD (SC true arm)
Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm"
Overall Number of Participants Analyzed 111 223 223
Overall Number of Units Analyzed
Type of Units Analyzed: CSAE
82 84 65
Measure Type: Number
Unit of Measure: score/month
0.112 0.128 0.075
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SC True, DC True
Comments

The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa < 0.05 and a power of 88.8%.

The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.14 to 0.67
Estimation Comments An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an ‘offset’.
2.Secondary Outcome
Title Number of Each of the Components of the CSAE
Hide Description

The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.

Number of each of the components of CSAE, counts the number of events for each pre-determined level.

Time Frame 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SC True SC Simulated DC True
Hide Arm/Group Description:
Allocated to Single Chamber ICD (SC true arm)
Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm")
Overall Number of Participants Analyzed 111 223 223
Measure Type: Number
Unit of Measure: events
Death 10 11 4
Invasive intervention CV 11 12 10
Hospitalizations (>24h) or prolongued CV 42 51 47
Inappropiate shocks (>2 episodes) 13 7 3
Long Duration AT 6 3 1
Time Frame Duration of the enrollment+follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SC True SC Simulated DC True
Hide Arm/Group Description Allocated to Single Chamber ICD (SC true arm) Dual chamber ICD initially programmed as Single Chamber ICD (simulated Dual chamber ICD initially programmed as a DDED-DDDR ("DC true arm")
All-Cause Mortality
SC True SC Simulated DC True
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SC True SC Simulated DC True
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/111 (45.05%)      49/223 (21.97%)      44/223 (19.73%)    
Cardiac disorders       
Invasive interventions   11/111 (9.91%)  11 12/223 (5.38%)  12 9/223 (4.04%)  10
Hospitalization or prolongued hospitalizations   33/111 (29.73%)  42 32/223 (14.35%)  51 36/223 (16.14%)  47
General disorders       
Death   10/111 (9.01%)  10 11/223 (4.93%)  11 4/223 (1.79%)  4
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SC True SC Simulated DC True
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/111 (11.71%)      8/223 (3.59%)      3/223 (1.35%)    
Cardiac disorders       
Innapropiate shocks   10/111 (9.01%)  23 7/223 (3.14%)  14 2/223 (0.90%)  5
Sustain Symptomatic AT  [1]  5/111 (4.50%)  6 4/223 (1.79%)  4 1/223 (0.45%)  1
Indicates events were collected by systematic assessment
[1]
sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention

The follow-up might have been too short to reveal differences in heart failure-related hospitalizations and related mortality.

Premature crossovers are a limitation of RCT. However, our scoring system severely penalized this cross-overs.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr.A.Quesada
Organization: Hospital General Universitario de Valencia, Spain
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00157820     History of Changes
Other Study ID Numbers: SP-DATAS
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: March 10, 2011
Results First Posted: August 21, 2012
Last Update Posted: April 6, 2017